DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 3-4 and 8-19, are pending. Claims 10-19, are withdrawn. Claims 2 and 5-7, are cancelled. Claims 1, 3-4 and 8-9, are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 March 2026 has been entered.
Response to Amendments
Objections withdrawn from action:
The claim objections are amended.
Status of Rejections from action:
The rejection for Claims 1, 3-4 and 8-9 under 112(a) written description is amended in view of amendment.
The rejection for Claims 1, 3-4 and 8-9 under 112(a) enablement is amended in view of amendment.
The rejection for Claims 1, 3 and 8-9 under 112(b) is modified in view of amendment.
The rejection for Claims 8-9 under 112(d) is added in view of amendment.
The rejection for Claims 1 and 5-8 under 103 is withdrawn in view of amendment. Because the claims are directed to a method that happens in both rice and corn simultaneously, practicing the method in only one of the crops would fall outside the scope of the claimed invention and would not constitute infringement.
The rejection for Claims 3-4 and 9 under 103 is withdrawn in view of amendment. Because the claims are directed to a method that happens in both rice and corn simultaneously, practicing the method in only one of the crops would fall outside the scope of the claimed invention and would not constitute infringement.
Claim Objections
In claim 1 the recitation of “PHO1;2” and “ADP” should be spelled out the first time using them.
In claim 3 the recitation of “GIF1” should be spelled out the first time using it.
Claims 8-9 the recitation “shown in” is grammatically incorrect. Applicant is
advised to replace the limitation with --as set forth--.
Appropriate correction is required.
Claim interpretation
The claims are being interpreted to mean that up-regulating the expression or activity of PHO1;2 gene requires overexpressing exogenous the OsPHO1;2 or ZmPHO1;2 polypeptides having the amino acid sequence of SEQ ID NOs: 1, 2, or 3.
Claim Rejections - 35 USC § 112(a)(Written Description)
Claims 1, 3-4 and 8-9, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s disclosure is as follows.
Applicant describes overexpressing OsPHO1;2 (SEQ ID NO: 1) in rice, which leads to (i) promoting filling of crop kernels; (ii) increasing crop yield or biomass; (iii) enhancing ADP pyrophosphorylase activity; (iv) increasing the utilization rate of phosphorus in crops; and (v) improving the tolerance of crops to a low-phosphorus environment (Figs. 12-15).
Applicant also describes overexpressing ZmPHO1;2 (SEQ ID NOs: 2 or 3) in corn which leads to an increase in seed size and yield (see figures 16-17). Applicant describes overexpressing ZmPHO1;2 (SEQ ID NOs: 2 or 3) and ZmGIF1 (SEQ ID NO: 4) in maize (see figures 18), resulting in increased kernel number and grain yield per kernel.
Claims encompass both maize and rice plants comprising SEQ ID NOs: 1, 2, 3 or 4 to improve (i) promoting filling of crop kernels; (ii) increasing crop yield or biomass; (iii) enhancing ADP pyrophosphorylase activity; (iv) increasing the utilization rate of phosphorus in crops; and (v) improving the tolerance of crops to a low-phosphorus environment and claims 8-9 encompass polypeptides having 80% or more sequence homology with any one of SEQ ID NOs: 1- 4 by substitution, deletion, or addition of one or several residues, which can be up to the entire gene.
The claimed invention lacks adequate written description for the following reasons. Claims 1, 3-4 and 8-9, are directed to a method of improving crop traits by upregulating expression or activity in rice and corn, comprising a OsPHO1;2, ZmPHO1;2 and/or ZmGIF1 gene resulting in either:
(i) promoting filling of crop kernels;
(ii) increasing crop yield or biomass;
(iii) enhancing ADP pyrophosphorylase activity;
(iv) increasing the utilization rate of phosphorus in crops; and
(v) improving the tolerance of crops to a low-phosphorus environment.
The specification has only described overexpression of SEQ ID NOs:2 or 3 in rice results in improved grain size, fill and yield (i.e. (i)-(ii)). However, the specification has failed to described that maize overexpressing SEQ ID NOs: 2 or 3 improves all traits (i)-(v). the specification does not describe overexpressing ZmPHO1;2 in all maize varieties will confer all traits and does not provide a representative number of plants comprising said traits.
Additionally, Applicant has only described one example of maize overexpressing both ZmPHO1;2 (SEQ ID NO: 2 or 3) and ZmGIF1 (SEQ ID NO: 4). The specification fails to describe a maize plant overexpressing both ZmPHO1;2 and ZmGIF1 genes conferring all (i)-(v) traits. The lack of a representative samples in both rice and maize makes it unpredictable to identify plants conferring said traits. Therefore, one skilled in the art would appreciate that Applicant does not possess the genus of traits as claimed.
Claim 1 also encompasses enhancers or promoters. Yet the specification does adequately define or describe how “enhancers” increase expression or shown representative number of “enhancers” improving expression.
Moreover, claim 1 encompasses decreasing histone-methylation. The Applicant does not describe how to decrease methylation or how reduced methylation increases expression. Applicant does not describe where to decrease methylation or how one skilled in the art target this methylation site to inhibit its activity.
In claims 8 and 9 the polypeptides encompasses any polypeptides having 80% or more sequence homology with any one of SEQ ID NOs: 1- 4 by substitution, deletion, or addition of one or several residues, which can be up to the entire gene. This means that the polypeptides derived from said sequences could be completely structurally and functionally different, because they can contain substitutions, deletions, or additions up to the entire length of the sequence. The specification has not provided a representative number of sequences having at least 80% sequence homology with SEQ ID NOs:1-4, let alone having substitutions, deletions or additions.
Furthermore, the Applicant has not described what the conserved regions, domains, or motifs required to produce plant comprising this genus of polypeptide and having traits (i)-(v). The Applicant has not adequately described a representative number of sequences from this broad genus of polypeptides and that retain function.
Therefore, it is unclear which species within the population have PHO1;2 and GIF1 activity, specifically derivatives and fragments having at least 80% sequence homology with SEQ ID NOs:1-4, by substitutions, deletions, or additions up to the entire length of the sequence, where polypeptides structurally change resulting in a non-working polypeptide or functionally different.
Because of this lack of a description in the specification, one skilled in the art cannot produce the structures and their allelic variants, derivatives, homologs, and fragments with having at least 80% sequence homology to SEQ ID NOs: 1-4. Applicant does not describe a common structure or motifs for PHO1;2 and GIF1 genes shared by rice and corn that would allow one skilled in the art to produce their structures of PHO1;2 and GIF1 genes from other rice and maize species.
The claims encompass mutants, derivatives, fragments, and allelic variants of SEQ ID NO: 1-4, yet no variant structure has been described. The description of SEQ ID NOs: 1-3 (PHO1;2) isolated from Oryza sativa and SEQ ID NO:4 (GIF1) isolated from Z. mays is not representative of other PHO1;2 and GIF1 sequences from other rice and corn species.
Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to produce or determine such allelic variants, derivatives, homologs, and fragments with having at least 80% sequence homology to SEQ ID NOs: 1-4.
Claims 8-9 also encompass PHO1;2 and GIF1 polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4. This requires the specification to describe sequences encoding such polypeptides.
However, the specification does not describe PHO1;2 and GIF1 polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4, which leads to functional PHO1;2 and GIF1 polypeptide.
Polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4 would have 163, 110, 160, or 118 amino acid substitutions relative to SEQ ID NOs: 1-4. These polypeptides would encompass 19163, 19110, 19160 or 19118 distinct protein variants, respectively. In the absence of representative samples where in the sequence of SEQ ID NOs: 1-4 such variations can be sustained, one skilled in the art would not be led to believe that Applicant possesses this vast genus of polypeptides that retain the activity of SEQ ID NOs: 1-4, and lead to traits (i)-(v).
For example, the specification fails to describe a representative number of species within the population of sequences with 80% identity to SEQ ID NO: 1, 2, 3 or 4 that encode functional PHO1;2 and GIF1 proteins in rice and corn, respectively.
For example, Zhang et al. “Response of ZmPHO1 family members to low phosphorus stress and association of natural variation in ZmPHO1;2a reveal the role of low phosphorus tolerance”, 2024, Plant physiology and biochemistry : PPB 219: 109417. (U), describes that “the expression levels of ZmPHO1;2a in the roots of 178 increased by 1.9 times, 2.7 times and 2.4 times at 24h, 48h and 96h after low-Pi stress, respectively; the expression levels of ZmPHO1;2b increased by 3.98 times and 7.78 times at 24h and 48h” (see page 5 col.1 and Fig. 2). Suggesting, that expression levels and locality depend on the co-ortholog variant.
Additionally, Liu et al. “The Conserved and Unique Genetic Architecture of Kernel Size and Weight in Maize and Rice.” Plant physiology vol. 175,2 (2017): 774-785.(previously presented) describes “that ZmINCW1 has conserved function for kernel/seed weight in maize and Arabidopsis and that expression regulation by cis-elements might be the cause of the phenotypic change. This is very different from rice GIF1, where a one-nucleotide deletion caused the premature termination of its open reading frame. These findings suggest that even though these genes have conserved functions, the types of genetic variation important for the phenotype may be different between species.” (see page 782 left column middle paragraph).
This suggests that PHO1;2 and GIF1 genes may function differently if structure changes between rice and corn, and showing that the Applicant has not adequately described the functional role of PHO1;2 and GIF1 in a representative number of plants at the time of filling.
In regard to claim 9 recites SEQ ID NO: 4 has the function of “regulating traits”. However, the specification has not described what traits SEQ ID NO: 4 regulates or provided representative number of traits that are, in fact, regulated. Therefore, one skilled in the art would appreciate that Applicant does not possess the genus of traits as claimed.
Applicant failed to describe a representative number of species from the genus or of sequences or a described structural features common to the members of the genus to demonstrate possession of the methods as claimed.
Finally, it is noted that claim 1 encompasses PHO1;2 wherein the activity or expression is increased yet the claim does not require the activity or expression to arise from the introduction of an exogenous nucleic acid encoding PHO1;2. Applicant has not described how, other than by the exogenous expression of PHO1;2 expression is increased.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 1, 3-4 and 8-9, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for overexpressing OsPHO1;2 (SEQ ID NO: 1) in rice, is not enabled for both maize and rice plants comprising SEQ ID NOs: 1, 2, 3 or 4 to improve traits (i)-(v) as claimed and is not enabled for polypeptides having 80% or more sequence homology with any one of SEQ ID NOs: 1- 4. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
(A) The breadth of the claims
The breadth of the claims encompasses any rice or maize plant with improved traits of: (i) promoting filling of crop kernels; (ii) increasing crop yield or biomass, by overexpressing (iii) enhancing ADP pyrophosphorylase activity; (iv) increasing the utilization rate of phosphorus in crops; and (v) improving the tolerance of crops to a low-phosphorus environment, and overexpressing SEQ ID NO: 1 (PHO1;2) and 4 (GIF1) or homologs, variant, derivative, or fragments to SEQ ID NO: 1-4.
(B)The nature of the invention
The nature of the claimed invention is directed to up-regulation expression or activity of SEQ ID NOs: 1-4 can improve crop traits (i)-(v) in O. sativa and Z. mays, or homologs, variants, derivatives, and fragments to SEQ ID NO: 1-4.
(D) The level of one of ordinary skill
The level of one of ordinary skill in the art is high.
(E)The level of predictability in the art; (F)The amount of direction provided by the inventor; (G)The existence of working examples; and (H)The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claimed invention lacks adequate enabling experimentation for the following reasons. Claims 1, 3-4 and 8-9, are directed to a method of improving crop traits by upregulating expression or activity in rice and corn, comprising a OsPHO1;2, ZmPHO1;2 and/or ZmGIF1 gene resulting in either:
(i) promoting filling of crop kernels;
(ii) increasing crop yield or biomass;
(iii) enhancing ADP pyrophosphorylase activity;
(iv) increasing the utilization rate of phosphorus in crops; and
(v) improving the tolerance of crops to a low-phosphorus environment.
The specification has only taught that overexpression of SEQ ID NOs:2 or 3 in rice results in improved grain size, fill and yield (i.e. (i)-(ii)). However, the specification has failed to provide enabling guidance for maize overexpressing SEQ ID NOs: 2 or 3 to improve all of traits (i)-(v) or provide working examples with plants that confer all traits claimed. It is unclear whether overexpressing ZmPHO1;2 in all maize varieties will confer all traits without undue experimentation to produce plants conferring said traits.
Additionally, Applicant has only taught one example of maize overexpressing both ZmPHO1;2 (SEQ ID NO: 2 or 3) and ZmGIF1 (SEQ ID NO: 4). The specification fails to provide working example of maize plants overexpressing both ZmPHO1;2 and ZmGIF1 genes conferring all (i)-(v) traits. The lack of working samples in both rice and maize makes it unpredictable to produce plants conferring said traits without undue experimentation.
Claim 1 also encompasses enhancers or promoters. Yet the specification does adequately teach or provide guidance for making and/or using “enhancers” that increase expression or and has not provided working examples of “enhancers” for improving expression making it unpredictable for the skilled artisan to use these enhancers.
Moreover, claim 1 encompasses decreasing histone-methylation. The specification does not teach how to decrease methylation or how reduced methylation increases expression. The specification does not teach where to decrease methylation or how one skilled in the art target this methylation site to inhibit its activity without undue experimentation.
In claims 8 and 9 the polypeptides encompass any polypeptides having 80% or more sequence homology with any one of SEQ ID NOs: 1- 4 and includes substitutions, deletions, or additions of one or several residues in the amino acid, which can be up to the entire gene. The specification has not provided working examples of these sequences having at least 80% sequence homology with SEQ ID NOs:1-4, let alone having substitutions, deletions or additions.
Furthermore, the specification has not taught conserved regions, domains, or motifs required to produce functional polypeptides to yield plant with traits (i)-(v). The specification has failed to teach how to predictably produce said sequences that retain functionality. Therefore, it is unpredictable which species within the population would also have PHO1;2 and GIF1 activity.
From the teachings of SEQ ID NOs: 1-4 one skilled in the art cannot predict the structures in a sequence having at least 80% sequence homology to SEQ ID NOs: 1-4 that confers functional activity. The specification does not teach a common structure or motifs for PHO1;2 and GIF1 genes shared by rice and corn that would allow one skilled in the art to produce their structures of PHO1;2 and GIF1 genes from other rice and maize species.
The specification teaches SEQ ID NOs: 1-3 (PHO1;2) isolated from Oryza sativa and SEQ ID NO:4 (GIF1) isolated from Z. mays. These teachings are not representative of other PHO1;2 and GIF1 sequences from other sources. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine their function.
Also, claims 8-9 encompass PHO1;2 and GIF1 polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4. This requires the specification to teach sequences encoding such polypeptides.
However, the specification does not PHO1;2 and GIF1 polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4, which leads to functional PHO1;2 and GIF1 polypeptide.
Polypeptides with at least 80% sequence homology to SEQ ID NOs: 1-4 would have 163, 110, 160, or 118 amino acid substitutions relative to SEQ ID NOs: 1-4. These polypeptides would encompass 19163, 19110, 19160 or 19118 distinct protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NOs: 1-4 such variations can be sustained, undue trial and error experimentation would be required to make the claimed polypeptides that retain the activity of SEQ ID NOs: 1-4, and lead to traits (i)-(v).
For example, it is unpredictable which species within the population would also have PHO1;2 and GIF1 activity in rice and corn. For example, Zhang et al. “Response of ZmPHO1 family members to low phosphorus stress and association of natural variation in ZmPHO1;2a reveal the role of low phosphorus tolerance”, 2024, Plant physiology and biochemistry : PPB 219: 109417. (U), teaches that “the expression levels of ZmPHO1;2a in the roots of 178 increased by 1.9 times, 2.7 times and 2.4 times at 24h, 48h and 96h after low-Pi stress, respectively; the expression levels of ZmPHO1;2b increased by 3.98 times and 7.78 times at 24h and 48h” (see page 5 col.1 and Fig. 2). This suggests that expression levels and locality depend on the co-ortholog variant.
Additionally, Liu et al. (The Conserved and Unique Genetic Architecture of Kernel Size and Weight in Maize and Rice.” Plant physiology vol. 175,2 (2017): 774-785.(previously cited)) teaches “that ZmINCW1 has conserved function for kernel/seed weight in maize and Arabidopsis and that expression regulation by cis-elements might be the cause of the phenotypic change. This is very different from rice GIF1, where a one-nucleotide deletion caused the premature termination of its open reading frame. These findings suggest that even though these genes have conserved functions, the types of genetic variation important for the phenotype may be different between species.”, (see page 782 left column middle paragraph).
Suggesting that PHO1;2 and GIF1 genes may function differently between rice and corn, and showing that the specification has not provided adequate guidance for predictability making PHO1;2 and GIF1.
In regard to claim 9 recites SEQ ID NO: 4 has the function of “regulating traits”. However, the specification has not taught what traits SEQ ID NO: 4 regulates or provided working examples of traits regulated by said gene. Therefore, the skilled artisan would be unable to predictably produce a plant that regulates all traits without undue experimentation.
The specification has failed to adequately teach a representative number of sequences from the genus of sequences as claimed or teach the structural features common to the members of the genus that confer functionality.
Additionally, the specification has failed to show a representative number of variants, fragments, derivatives of SEQ ID NO: 1 and 4, to improve crop traits. Furthermore, Applicant does not enable one skilled in the art to create such homologs, variants, fragments, derivatives having 80% homology to SEQ ID NOs: 1-4 without proper identifying alignments, structures and conserved regions that would produce an effective homolog, variant, fragment, or derivative. One skilled in the art found find it unpredictable to produce plant with sequence with at least 80% sequence identity retaining (i)-(v) traits.
Accordingly, the claimed genus of plants wherein the up-regulation expression or activity of SEQ ID NOs: 1-4 can confer improved crop traits in rice and corn lacks adequate enablement. It is also noted that claim 1 encompasses PHO1;2 activity increased expression or activity that does not occur from expression of the exogenous nucleic acid.
Applicant has not taught how, other than by the exogenous expression of PHO1;2 expression is increased. Therefore, it is unpredictable how else the PHO1;2 expression is upregulated.
Furthermore, due to the high number of variations between to separate genes, the complexity of protein-to-protein interactions, and structure to function relationship, the specification has failed to teach one skilled in the art to produce a plant comprising said genes to effectively confer enhanced the listed traits in claim 1 to rice and corn.
The specification has failed to enable a representative number of species within the scope of the genus and failed to teach the structural features common to the members of the genus.
Given the lack of sufficient guidance, examples of operable embodiments, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are addressed below.
Applicant did not argue besides amending the claims 1 and 3 to limit the crops to rice and maize, and to limit up-regulating OsPHO1;2 (SEQ ID NO: 1) in rice and ZmPHO1;2 (SEQ ID NOs: 2-3) in maize. Applicant has also amended claim 3 to limit up-regulating ZmGIF1 (SEQ IDNO: 4) in maize and that the rejection should be reconsidered because the amendment satisfies the rejection.
(Remarks, March 23, 2026, page 9).
This argument has been fully considered but not found persuasive.
MPEP says," An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000)." (MPEP, 2163/II,A,3, (a)).
In the instant case, one skilled in the art cannot predictably reproduce sequences derived from the polypeptide of (1) and having 80% or more sequence homology with any one of SEQ ID NOs: 1-4 by substitution, deletion, or addition, up to the entire length of the sequence, where polypeptides structurally change resulting in a non-working polypeptide or functionally different.
The disclosure of SEQ ID NO: 1-3 (PHO1;2) isolated from Oryza sativa and SEQ ID NO:4 (GIF1) isolated from Z. mays is not representative of other PHO1;2 and GIF1 sequences from other sources, respectively. These sequences can be altered in numerous combinations which would result in undue experimentation. It is unclear which of these combinations would result in a sequence having any of the functions listed in claim 1.
Furthermore, Applicant has not described or taught, which regions to retain, since mutations outside of the transmembrane domains can alter activity without touching the conserved regions.
At least for these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 112(b)(New)
Claims 1 and 3, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 the recitation of “2-3” is unclear. This limitation is unclear because the specification does not define “2-3”, and it is not clear if “2-3” means both SEQ ID NO: 1 and 2, of if the claims encompasses SEQ ID NO: 1 or 2.
Claim 1 the recitation of “enhancer” is unclear. The specification does not adequately define the term.
In claims 1 and 3, it is unclear whether the recitations with respect to the sequence identifies within the parentheses are intended to be claim limitations or nonlimiting examples.
Claims 4, 8 and 9 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
Claim Rejections - 35 USC § 112(d)(new)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-9, are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 8-9 further broadens the scope of the claims from which they depend by having 80% or more sequence homology with any one of the sequence identifiers. Therefore, claims 8-9 do not further limit the claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
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/C.J.O./Examiner, Art Unit 1663
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
